Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

— Toco-Ovar  

Official title:

Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399592
• Other study ID #: Toco-Ovar
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: July 2019

Study information

• Verified date: February 2020
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.

• Prior treatment with at least two different cytostatic regimens including platinum.

• Progression on previous treatment.

• Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria.

• Age = 18 years.

• Performance stage 0-2.

• Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

• WBC = 3.0 * 10^9/l or neutrophils (ANC) = 1.5 * 109/l

• Platelet count = 100 * 10^9/l

• Hemoglobin = 6 mmol/l

• Serum bilirubin < 2.0 * ULN

• Serum transaminase = 2.5 * ULN

• Serum creatinine = 1.5 ULN

• Urine dipstick for protein <2+. If the dipstick shows protein =2+ 24 hour urine testing must be made with protein contents < 1 g.

• Written informed consent.

Exclusion Criteria:

• Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.

• Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.

• Underlying medical disease not adequately treated (diabetes, cardiac disease).

• Uncontrolled hypertension (BT >150/100 despite antihypertensive treatment).

• Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab.

• Non-healing wounds or fractures.

• Cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment.

• Clinically significant cardiovascular disease, including:

• Myocardial infarction or unstable angina within 6 months before start of treatment

• New York heart Association (NYHA) class = 2

• Poorly controlled cardiac arrhythmia despite medication

• Periferal vascular disease grade = 3

• Allergy to the active substance or any of the auxiliary agents

• Bleeding tumor

• Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.

• Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Bevacizumab
10 mg/kg q3w
• Tocotrinol
300 mg tid

Locations

Country	Name	City	State
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fraction of patients without progression after six months of treatment		6 months after start of treatment